JETREA® (ocriplasmin) solution for intravitreal injection now available to Canadian patients

JETREA® (ocriplasmin) solution for intravitreal injection now available to
Canadian patients
-- First and only eye medicine to treat sight-threatening,
symptomatic vitreomacular adhesion affecting 15,000 Canadians
each year
MISSISSAUGA, ON, Nov. 20, 2013 /CNW/ - Alcon, the global leader in eye care
and a division of Novartis, announced today that JETREA(® )(ocriplasmin)
solution for intravitreal injection is now available to Canadians who suffer
from symptomatic vitreomacular adhesion.(1,2 )Vitreomacular adhesion, or VMA,
is an age-related, progressive and sight-threatening condition. If left
untreated, it can be responsible for retinal distortion, decreased visual
acuity, and vision deterioration, with the potential to cause irreversible
vision loss or blindness.(3,4,5,6) It is estimated to affect up to 15,000
people in Canada each year.(7 )Health Canada approved JETREA(® )on August
13, 2013.
"Before JETREA(®), the only option we had for treating VMA was surgical
intervention," said David Chow, MD, Retina Specialist and Director of the
Toronto Retina Institute. "Now with the availability of JETREA(®), we have a
non-surgical option that can be offered during the early stages of VMA, which
can make a difference in terms of quality of life for people living with this
condition."
JETREA(®) (ocriplasmin), a recombinant form of human protein (plasmin), works
by targeting the protein fibers that cause the abnormal pull between the
vitreous and the macula of the eye. By dissolving these proteins, JETREA(®)
separates the vitreous from the macula, releasing the vitreomacular
adhesion.(2,8) This one-time intravitreal injection has been shown to
successfully resolve VMA.(1,2)
The Phase III studies, published in the New England Journal of Medicine,
showed that patients who were treated with JETREA(®) (ocriplasmin)
successfully achieved resolution of VMA as compared to placebo at day 28.(1)
In the integrated Full Analysis Set, 26.5% of the patients treated with
JETREA(®) achieved resolution of VMA at Day 28 (versus 10.1% with placebo
[P<0.001]).(1)
Side effects observed in the Phase III studies of JETREA(®) (ocriplasmin)
were consistent with the release of traction and intravitreal injections. The
most common Adverse Drug Reactions were consistent with pharmacologic
vitreolysis, such as vitreous floaters, photopsia, or were due to
inflammation/irritation resulting from either the injection procedure and/or
the drug. These were generally considered mild to moderate and were resolved
without complications.(1 )
"At the core of our corporate mission is to provide innovative products to
improve the quality of life by helping people see better," said Alex Long,
General Manager of Alcon Canada. "We are pleased to offer patients in Canada
the first and only pharmacological treatment for this progressive eye disease."
Alcon acquired the rights to commercialize JETREA(®) injection outside the
United States from the Belgian biopharmaceutical company, ThromboGenics, which
retains the rights to commercialize the drug in the US. In October 2012,
JETREA(®) intravitreal injection was approved in the US for the treatment of
patients with symptomatic VMA. European approval for JETREA(®) (ocriplasmin)
was granted in March 2013 for the treatment of vitreomacular traction (VMT),
including when associated with macular hole equal to or smaller than 400
microns. Healthcare professionals can access more information at alcon.ca.
About VMA
As people get older, the vitreous (jelly-like material inside the eye that
helps maintain the round shape) detaches naturally from the retina (the
light-sensitive layer of tissue located at the back of the eyeball).(13) This
detachment is part of the natural aging process and is common over the age of
50.
However, sometimes the vitreous remains attached to some areas of the retina,
particularly at the macula, which is the area of the retina responsible for
central vision needed for everyday tasks, such as driving, reading and
recognizing faces. This is known as vitreomacular adhesion (VMA).(13)
If left unresolved, these areas of VMA can exert a 'pulling force' on the
macula, a condition referred to as vitreomacular traction (VMT). In some
cases, the pulling due to VMT may eventually tear the macula, leading to the
formation of a macular hole.(2,13) Symptomatic VMA is a progressive condition
that is often responsible for retinal distortion and deterioration in vision,
and has the potential to cause irreversible damage or blindness.(3,4,5,6)
About Alcon
Alcon, the global leader in eye care, provides innovative products that
enhance quality of life by helping people worldwide see better. The three
Alcon businesses - Surgical, Pharmaceutical and Vision Care - offer the widest
spectrum of eye care products in the world. Alcon is the second largest
division of the Novartis Group with pro-forma sales of USD 10 billion in 2011.
Headquartered in Fort Worth, Texas, U.S.A, Alcon has 23,000 employees
worldwide, operations in 75 countries and products available in 180 markets.
For more information, visit www.alcon.com.
JETREA is a trademark of ThromboGenics N.V., licensed to Alcon
References
1. Stalmans P, Benz MS, Gandorfer A et al. Enzymatic vitreolysis with
ocriplasmin for vitreomacular traction and macular holes. N Engl J
Med 2012;367:606-615
2. Jetrea(®) Product Monograph, August 2013
3. Schneider EW, Johnson MW. Emerging nonsurgical methods for the
treatment of vitreomacular adhesion: a review. Clin Ophthalmol.
2011;5:1151-1165
4. Hikichi T, Yoshida A, Trempe C. Course of vitreomacular traction
syndrome. Am J Ophthalmol. 1995;119(1):55-61
5. Carpineto P,Di Antonio L,Aharrh-Gnama A et al. Diagnosing and
Treating Vitreomacular Adhesion. Retina 2011 69-73
6. Bottós, Juliana, et al. Vitreomacular Traction Syndrome. Journal
of Opthalmalic and Vision Research. 2012;7(2):148-161
7. Alcon internal estimates/data on file
8. Sebag J. Anomalous posterior vitreous detachment: a unifying
concept in vitreo-retinal disease. Graefe's Arch Clin Exp
Ophthalmol. (2004) 242:690-698
9. ICO Guidelines MH 2010/A - ICO International Clinical Guidelines.
November 2010
10. Sugiyama A, et al. Reappraisal of spontaneous closure rate of
idiopathic full-thickness macular holes. Open Ophthalmol J.
2012;6:73-74
11. Barak Y, Ihnen M, Schaal S. Spectral domain optical coherence
tomography in the diagnosis and management of vitreoretinal
interface pathologies. J Ophthalmol. 2012.doi:10.1155/2012/876472
12. Gallemore RP, et al. Diagnosis of vitreoretinal adhesions in
macular disease with optical coherence tomography. Retina. 2000;20
(2): 115-120
13. Dugel P. Retina Today April 2012;50
14. Data on file, Summary of Clinical Overview. ThromboGenics Inc,
2012
SOURCE Alcon Canada Inc.
Media Inquiries: Donna Lorenson Alcon U.S./Canada Communications
817.615.5092 donna.lorenson@alcon.com
Matt Roth MSLGROUP 416.847.1305 matt.roth@mslgroup.com
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CO: Alcon Canada Inc.
ST: Ontario
NI: MTC NP HEA
-0- Nov/20/2013 16:06 GMT